BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1850829 · Received September 28, 2010

    Report

    Report Number
    3007566237-2010-07376
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BROKEN AT THE SPINAL ANCHOR SITE. THE BROKEN CATHETER WAS DISCOVERED DURING A PUMP REPLACEMENT DUE TO END OF SERVICE OF THE DEVICE. A NEW SPINAL SEGMENT OF CATHETER WAS IMPLANTED. THE PT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE BROKEN CATHETER AND RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention CATHETER: MODEL 8731, LOT# N002227528.| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# N002227528